Class 2 Device Recall ATTUNE FIXED BEARING KNEE

• Date Initiated by Firm: February 22, 2021
• Create Date: March 29, 2021
• Recall Status: Terminated on October 11, 2023
• Recall Number: Z-1314-2021
• Recall Event ID: 87433
• 510(K)Number: K170806
• Product Classification: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
• Product: ATTUNE¿ FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant without a porous coating. The tibial component may be an all polyethylene component or comprised of a metal tibial base without porous coating, and a polyethylene insert and locking components. The patella component may be of an all polyethylene design.
• Code Information: Lot#: 9558300, Product Code: 150670003, GTIN 10603295492054 Lot#: 9555958, Product Code: 150670004, GTIN 10603295492061 Lot#: 9554006, Product Code: 150670005, GTIN 10603295492078 Lot#: 9556397, Product Code: 150670005, GTIN 10603295492078 Lot#: 9558618, Product Code: 150670006, GTIN 10603295492085 Lot#: 9557992, Product Code: 150670007, GTIN 10603295492092 Lot#: 9558238, Product Code: 150670008, GTIN 10603295492108 Lot#: 9558239, Product Code: 150670008, GTIN 10603295492108 Lot#: 9555613, Product Code: 150670009, GTIN 10603295492115
• Recalling Firm/ Manufacturer: DePuy Orthopaedics, Inc.; 700 Orthopaedic Dr; Warsaw IN 46582-3994
• For Additional Information Contact: Kimberly Long; 574-221-8156
• Manufacturer Reason for Recall: Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affected tibial bases are designed to be used in cemented applications.
• FDA Determined Cause: Packaging change control
• Action: On 02/25/2021, Depuy Synthes issued an Urgent Medical Device Recall notices to customers via email. DePuy (Ireland) UC is initiating a voluntary removal for the 12 lots for ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affected tibial bases are designed to be used in cemented applications.
• Quantity in Commerce: 102 units total (Domestic: 6 units, Foreign: 86 units)
• Distribution: Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA, VT, WA, WI, WV and the countries of Brazil, Austria, Belgium, Denmark, Estonia, France, Germany, Great Britain, Ireland, Israel, Italy, Macedonia, Mauritius, Netherlands, Norway, Poland, Romania, Slovakia, Slovenia, South Africa, Sweden, Switzerland, United Arab Emirates, China, Hong Kong, Japan, New Zealand, Korea, Singapore, Thailand.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JWH and Original Applicant = DePuy (Ireland)